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Biomedical subjects

B Winikoff

Publications and source records attributed to B Winikoff.

At least 19 recordsLinked to original sources
PubMed2007

Are two doses of misoprostol after mifepristone for early abortion better than one?

OBJECTIVE: The objective of this study was to determine if a repeat dose of misoprostol following mifepristone or a single dose of misoprostol increases the efficacy of medical termination of pregnancy. DESIGN: Randomised, placebo controlled trial. SETTING: K.E.M. Hospital, Pune, India, and the Health Centre, Larsen and Toubro Limited, Mumbai, India. SAMPLE: A total of 300 women seeking an abortion with amenorrhoea of 8 weeks or less. Methods Women were randomised to receive one or two doses of 400 microgram oral misoprostol at the clinic 48 hours after administration of 200 mg mifepristone. Main outcome measure Complete abortion without surgical intervention. Results The repeat administration of misoprostol 400 microgram improved the complete abortion rate from 86 to 92% and significantly reduced the rate of continuing pregnancy from 7 to 1%. Almost all the women who were administered the additional dose of misoprostol were either very satisfied (58%) or satisfied (37%) with the method. Conclusion While an additional oral dose of 400 microgram misoprostol did not significantly increase the rate of complete abortion without surgical intervention, the additional dose did significantly reduce the rate of continuing pregnancies without compromising the acceptability and ease of use of the method.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial.

OBJECTIVE: To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion. DESIGN: Randomised nonblinded trial. SETTING: Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area. POPULATION: Women of reproductive age. METHODS: Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period. MAIN OUTCOME MEASURES: Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975). RESULTS: Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability. CONCLUSIONS: There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Home use of two doses of misoprostol after mifepristone for medical abortion: a pilot study in Sweden and France.

OBJECTIVE: To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings. METHODS: One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 microg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen. RESULTS: Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively). CONCLUSIONS: Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful.

Abortifacient Agents↗
PubMed2005

Knowledge and attitudes about abortion legislation and abortion methods among abortion clients in Latvia.

OBJECTIVE: To assess knowledge of abortion legislation and knowledge and attitudes about medical and surgical abortion among women seeking a legal abortion in Latvia. METHODS: Data are drawn from a survey of 371 abortion clients from 16 purposively selected abortion clinics in Latvia. A semi-structured questionnaire was used to collect socio-demographic data and information on women's knowledge of and attitudes toward abortion law and abortion methods. RESULTS: Most women knew that abortion is legal either under any (53%) or certain (37%) circumstances. Almost one third (31%) of women interviewed were aware of medical abortion. After hearing a description of medical abortion, respondents felt the method as described would be advantageous because it could avoid a surgical intervention (33%) or found it simple, easy, convenient, or natural (12%). Women were concerned that the method might not be completely effective (38%) or be associated with side-effects (22%). CONCLUSIONS: Respondents were interested in medical abortion as a less invasive option to surgical abortion. Efforts should be undertaken to inform women about the safety and efficacy of the method.

Abortion, Induced↗
PubMed2004

Medical treatment of missed abortion using misoprostol.

OBJECTIVE: To compare the efficacy of two routes of misoprostol administration (oral and vaginal) for treatment of missed abortion. METHODS: Two hundred women with confirmed missed abortion received 800 mcg misoprostol either orally or vaginally. All women returned for follow-up care 2 days later. If the pregnancy was not completely evacuated at this time, women could wait an additional 5 days or undergo immediate surgical completion. Efficacy was defined as the percent of women discharged from the study without need for surgical intervention. RESULTS: Efficacy was high in both groups and not statistically different (oral=89.0%, vaginal=92.9%). While the groups did not differ in terms of the completion rate by day 2 (oral=41.6%, vaginal=52.7%), the mean time to expulsion was longer (21.04 h) in the oral group than the vaginal group (13.47 h), p=0.041. Women in both groups were highly satisfied with the method. CONCLUSIONS: Medical management of missed abortion with either oral or vaginal misoprostol is highly effective and highly acceptable.

Abortifacient Agents, Nonsteroidal↗
PubMed2002

Misoprostol use in obstetrics and gynecology in Brazil, Jamaica, and the United States.

OBJECTIVES: To investigate current clinical use of misoprostol for the treatment of a range of reproductive health indications by providers in Brazil, Jamaica, and the United States. METHODS: Using a 'snowball' sampling technique, we surveyed 228 gynecologists and obstetricians in Brazil (n=123), Jamaica (n=52), and the United States (n=53). RESULTS: Providers use misoprostol for labor induction (46%), postpartum hemorrhage (8%), intra-uterine fetal death (61%), cervical priming (21%), missed abortion (57%), and incomplete abortion (16%) as well as first and second trimester abortion induction (27% and 13%, respectively). CONCLUSIONS: There is considerable variation in the regimens used; moreover, the regimens commonly used in clinical practice often differ from those recommended in the medical literature. While misoprostol is an appealing alternative for many reproductive health indications in developing countries, the varied regimens and lack of registration raise critical medical and policy questions.

Brazil↗
PubMed2001

The etiology of maternal mortality in developing countries: what do verbal autopsies tell us?

OBJECTIVE: To reassess the practical value of verbal autopsy data, which, in the absence of more definitive information, have been used to describe the causes of maternal mortality and to identify priorities in programmes intended to save women's lives in developing countries. METHODS: We reanalysed verbal autopsy data from a study of 145 maternal deaths that occurred in Guerrero, Querétaro and San Luis Potosí, Mexico, in 1995, taking into account other causes of death and the WHO classification system. The results were also compared with information given on imperfect death certificates. FINDINGS: The reclassification showed wide variations in the attribution of maternal deaths to single specific medical causes. CONCLUSION: The verbal autopsy methodology has inherent limitations as a means of obtaining histories of medical events. At best it may reconfirm the knowledge that mortality among poor women with little access to medical care is higher than that among wealthier women who have better access to such care.

Adult↗
PubMed2001

Can women in less-developed countries use a simplified medical abortion regimen?

BACKGROUND: Mifepristone-misoprostol abortion, consisting of oral pills, is potentially simple and safe enough for use in less-developed countries. But the labour-intensive, costly, clinic-based European protocols are not affordable or feasible in most less-developed countries. METHODS: We prospectively tested two simplifications to the French mifepristone-misoprostol regimen in Vietnam and Tunisia. Women (n=315) with amenorrhoea 8 weeks or less since their last menstrual period received 200 mg mifepristone in the clinic and then chose whether to take 400 mg oral misoprostol 2 days later either at home or in the clinic. FINDINGS: Despite the two-thirds reduction in mifepristone dose, success rates were high: Vietnam 93%, Tunisia 91%. About 88% of participants chose home administration of misoprostol. Most Vietnamese and Tunisian women were satisfied with their abortions, but efficacy and satisfaction rates were higher among those who used misoprostol at home. INTERPRETATIONS: A simplified medical abortion regimen of 200 mg mifepristone followed by the option of home administration of misoprostol seems feasible.

Abortifacient Agents↗
PubMed2001

Mifepristone abortion outside the urban research hospital setting in India.

Medical abortion holds great promise in less-developed countries, where abortion morbidity and mortality remain high. We tested the French mifepristone-misoprostol regimen in two urban outpatient family-planning clinics (n=600) and a rural hospital (n=300) in India. 4% of urban women and 1% of rural women were lost to follow-up. Perfect use and typical-use success rates were as high as European rates at all sites. Although rural women reported fewer side-effects, most women in urban and rural settings were satisfied with their medical abortions. Medical abortion can be offered safely, effectively, and acceptably in urban outpatient clinics and rural hospitals in India.

Abortifacient Agents, Steroidal↗
PubMed2001

Validity of women's self-reported obstetric complications in rural Ghana.

This retrospective study assessed the utility of women's self-reports to identify obstetric complications in rural Ghana. All consenting obstetric and postpartum inpatients, presenting from the seventh month of gestation to 42 days postpartum, were interviewed at the Holy Family Hospital, Techiman and were asked about their signs and symptoms. A combination of clinical examination and laboratory testing of urine and blood samples was used for determining case status. Self-reported obstetric complications of 340 women were compared with the corresponding diagnostic status for their sensitivity, specificity, predictive value, and test-efficiency. Using algorithms that could not be practically applied at the community level, self-reported symptoms correctly identified the majority (75%) of complicated and uncomplicated pregnancies, but missed one-quarter of cases requiring emergency obstetric care. The positive predictive value of 50% indicates that women's self-reported symptoms should not be used in estimating the incidence of these conditions or in identifying women requiring referral in this population.

Algorithms↗
PubMed2000

Predictors of analgesia use during supervised medical abortion. The Mifepristone Clinical Trials Group.

The object of this analysis was to identify predictors of narcotic analgesic use during medical abortion. A total of 2121 women with pregnancies of </=63 days gestational age received 600 mg mifepristone followed 48 h later by 400 microg oral misoprostol in a single arm clinical trial perfomed at 17 centers in the US. We tested the effects of subject characteristics at baseline and study centers on the use of any narcotic analgesics on the day of misoprostol use. Overall, 27% of subjects received narcotic analgesics. The main determinant of narcotic analgesic use was the study center. The relative risk of using narcotic analgesics increased with gestational age; the relative risk decreased in women with previous births, and also decreased with increasing age of the woman receiving treatment. It is concluded use of narcotic analgesia during medical abortion is least likely among older, parous women at low gestational ages; however, the clinic providing care for the patient was the most important determinant of who received narcotic analgesia.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Reduction of the cesarean delivery rate in Ecuador.

OBJECTIVE: This quasi-experimental study tested a method to safely reduce the rate of cesarean delivery in Ecuador. METHOD: Hospital policy was modified to provide co-management for cesarean candidates at the major maternity hospital in Quito. Cesarean rates before (n=14743) and after (n=12351) the intervention were compared by chi-square and multiple logistic regression with other major maternity hospitals (before, n=12514; after, n=9590). Characteristics of cesarean candidates who had vaginal or cesarean deliveries in the intervention hospital were compared by chi-square (n=1584). RESULT: Cesarean rates declined by 4.5% (P<0.001) in the intervention hospital. A smaller (2.1%, P<0.01) reduction occurred in the other major public hospital in Quito where students of the co-principal investigator attempted to reduce cesarean delivery. Cesarean rates were unchanged in the public maternity hospitals of other major cities. CONCLUSION: Case co-management, a simple, locally appropriate, and inexpensive intervention, safely reduced surgical delivery, hospital stay and cost of care.

Cesarean Section↗
PubMed2000

Abortion with mifepristone and misoprostol: regimens, efficacy, acceptability and future directions.

Mifepristone at a dose of 600 mg followed by 400 microg misoprostol orally has been used for early abortion by hundreds of thousands of women with success rates at </=49 days' gestation ranging from 92% to 97%. Newer regimens may prove simpler than this standard regimen and may serve a larger number of patients. Vaginal rather than oral administration of misoprostol may have advantages, including improvement in the efficacy of mifepristone regimens at >49 days' gestation. A lower mifepristone dose of 200 mg and in-home self-administration of misoprostol both appear safe and effective. Although most research protocols have used ultrasonography to confirm gestational age, the method can be provided safely without routine reliance on ultrasonography. Acceptability of the method to care providers and to patients has been high in all studies. The introduction of medical abortion into general medical practice in the United States will teach us much about the practical aspects of service provision.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Screening and syndromic approaches to identify gonorrhea and chlamydial infection among women.

The standard diagnostic tools to identify sexually transmitted infections are often expensive and have laboratory and infrastructure requirements that make them unavailable to family planning and primary health-care clinics in developing countries. Therefore, inexpensive, accessible tools that rely on symptoms, signs, and/or risk factors have been developed to identify and treat reproductive tract infections without the need for laboratory diagnostics. Studies were reviewed that used standard diagnostic tests to identify gonorrhea and cervical chlamydial infection among women and that provided adequate information about the usefulness of the tools for screening. Aggregation of the studies' results suggest that risk factors, algorithms, and risk scoring for syndromic management are poor indicators of gonorrhea and chlamydial infection in samples of both low and high prevalence and, consequently, are not effective mechanisms with which to identify or manage these conditions. The development and evaluation of other approaches to identify gonorrhea and chlamydial infections, including inexpensive and simple laboratory screening tools, periodic universal treatment, and other alternatives must be given priority.

Algorithms↗
PubMed2000

The power of information and contraceptive choice in a family planning setting in Mexico.

OBJECTIVES: This study measured the effect of information about family planning methods and STD risk factors and prevention, together with personal choice on the selection of intrauterine devices (IUDs) by clients with cervical infection. METHODS: We conducted a randomised, controlled trial in which family planning clients were assigned to one of two groups, the standard practice (control) group in which the provider selected the woman's contraceptive and the information and choice (intervention) group. The study enrolled 2107 clients in a family planning clinic in Mexico City. RESULTS: Only 2.1% of the clients had gonorrhoea or chlamydial infections. Significantly fewer women in the intervention group selected the IUD than the proportion for whom the IUD was recommended in the standard care group by clinicians (58.2% v 88.2%, p = 0.0000). The difference was even more pronounced among infected women: 47.8% v 93.2% (intervention v control group, p = 0.0006). CONCLUSIONS: The intervention increased the selection of condoms and reduced the selection of IUDs, especially among women with cervical infections, for whom IUD insertion is contraindicated.

Adult↗